Cleared Traditional

PROPHY ANGLE

K953628 · Rolence Enterprise Co. , Ltd. · Dental
Sep 1995
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K953628 is an FDA 510(k) clearance for the PROPHY ANGLE, a Cup, Prophylaxis (Class I — General Controls, product code EHK), submitted by Rolence Enterprise Co. , Ltd. (Chungli, Taiwan, TW). The FDA issued a Cleared decision on September 29, 1995, 60 days after receiving the submission on July 31, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.6290.

Submission Details

510(k) Number K953628 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1995
Decision Date September 29, 1995
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EHK — Cup, Prophylaxis
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6290